BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors

NCT05869240 | Unknown Phase 1

• 1 other identifier: BTP-61811
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, open-label, Phase I/II clinical study of BPB-101 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of BPB-101.

Conditions

Solid Tumor

Keywords

BPB101; solid tumor

Outcome Measures

Primary Outcomes (4)

• DLT of BPB-101

  DLT is defined as a dose-limiting toxicity event occurring during the DLT observation period that, as determined by the Investigator and/or Sponsor to be at least possibly related to BPB-101, is classified using NCI-CTCAE version 5.0 as conforming to adverse events (AEs) or laboratory anomalies specified in the protocol.

  Up to 21 days after first treatment in Phase Ia

• Maximum Tolerated Dose (MTD) of BPB-101

  MTD was defined as the maximum dose of \<1/3 DLT events observed in patients with evaluable DLT events (i.e., 1 in 6 patients at most).

  Up to 21 days after first treatment in Phase Ia

• RP2D of BPB-101

  RP2D is determined based on safety, tolerability, pharmacokinetics and efficacy data.

  Throughout Phase Ia and Ib，approximately 2 years

• Number of subjects with adverse events (AEs)

  An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.

  Up to 30 days after last treatment

Secondary Outcomes (11)

• Dose Escalation and Expansion Part: Maximum concentration (Cmax)

  Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

• Dose Escalation and Expansion Part: Minimum concentration (Cmin)

  Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

• Dose Escalation and Expansion Part: Area under the concentration-time curve from zero to last sampling time (AUC0-t)

  Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

• Dose Escalation and Expansion Part: Half-life (T1/2)

  Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

• Immunogenicity of BPB-101

  Predose of cycle 1, 2, 3, 4 (each cycle is 21 days), and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

Study Arms (1)

BPB-101

EXPERIMENTAL

Drug: BPB-101

Interventions

BPB-101 DRUG

Subjects will receive an intravenous infusion of BPB-101 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

BPB-101

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participate in the trial and sign an informed consent form.
• Male or female subjects aged between 18 and 75 years.
• Subjects with cytologically or histologically confirmed advanced solid tumor for which no standard therapy is available or standard therapy has failed in dose-escalation phase; In the dose-expansion phase, subjects enrollment included, but not limited to, with non-small-cell lung, esophageal, colorectal, endometrial, melanoma, bladder, and breast cancers (actual enrollment could be determined based on available data).
• Life expectancy \>= 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participants enrolled in the dose-escalation phase (phase Ia) must have evaluable disease per RECIST 1.1. Participants enrolled in the dose expansion and clinical expansion phase (phase Ib and II) must have at least one measurable disease per RECIST 1.1.
• Adequate hematologic and organ function at screening, as follows:
• Absolute neutrophil count (ANC)≥1.5×10\^9/L, Platelets≥100×10\^9/L, Hemoglobin≥9g/dL(90g/L)
• Serum total bilirubin ≤1.5×upper limit of normal (ULN), unless liver cancer or liver metastases are present, then values must be ≤2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, unless liver cancer or liver metastases are present, then values must be ≤5×ULN
• Serum creatinine≤1.5×ULN OR creatinine clearance (CrCl)≥50ml/min (using the Cockcroft-Gault formula)
• International normalized ratio (INR) and prothrombin time ≤1.5×ULN; And activated partial thromboplastin time (aPTT) ≤1.5×ULN.
• Female subjects with childbearing potential must have a negative serum pregnancy test at screening (within 7 days of first dose of study drug). Female subjects with childbearing potential and male subjects with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the screening visit through 6 months after the last dose of study drug is received.

You may not qualify if:

• Known hypersensitivity to any component and excipients of the investigational drug, or previous severe allergic reaction to any macromolecular monoclonal antibody.
• Received anti-PD-1 or PD-L1 antibodies within 3 months prior to screening. Previously received treatment targeting TGF-β, TGF-β receptors, or GARP.
• Received other antitumor therapies, such as chemotherapy, biological therapy, endocrine therapy, etc., within 4 weeks before the first dose. Local palliative treatment (such as local surgery or radiotherapy) for isolated lesions can be received without affecting the efficacy evaluation. Enrollment is permitted in the following cases:
• Oral pyrimidine or small molecule targeted therapy drugs are used more than 2 weeks or 5 half-lives of the drug (whichever is longer) before the first dose.
• Nitrosourea or mitomycin C are used more than 6 weeks before the first dose.
• Major surgery within 4 weeks before first dose of study drug.
• Systemic therapy with immunosuppressive agents within 2 weeks prior to the first dose of study drug or during the study, except for corticosteroid nasal sprays, inhalers, or ≤10 mg/day systemic prednisone and equivalent medications.
• Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 5 years.Except for malignancies that can be expected to heal after treatment (including but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or carcinoma in situ of the breast duct treated with radical surgery).
• Presence of symptomatic central nervous system metastases, meningeal metastases, or spinal cord compression due to metastases. Except for patients with brain metastases who have symptoms before the first dose, but whose disease is stable for ≥ 4 weeks after treatment.
• Subjects with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer; Those with a history of melena and hematemesis within 2 months before administration; Researchers believe that visceral bleeding may occur.
• Patients with large and uncontrolled pleural effusions, pericardial effusions, or abdominal effusions requiring repeated drainage.
• Has an active autoimmune disease requiring systemic treatment within 2 years prior to initial medication.
• Cardiovascular diseases of clinical significance, including:
• a. Clinically uncontrolled hypertension;
• The following conditions occurred within 6 months before the first medication:

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

NOT YET RECRUITING

Sichuan Academy of Medical Sciences-Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

Study Officials

• Li Zhang

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Weizhi Gu

CONTACT

0086-0571-85856809; weizhi.gu@bettapharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 22, 2023
• Study Start: May 16, 2023
• Primary Completion: August 2, 2025
• Study Completion: September 1, 2025
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)